This study will evaluate the safety, efficacy, and pharmacokinetics of UTTR1147A compared with placebo and compared with vedolizumab in patients with moderate to severe ulcerative colitis (UC).
ID
Source
Brief title
Condition
- Gastrointestinal ulceration and perforation
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To evaluate the efficacy of UTTR1147A compared with placebo and compared with
vedolizumab
Secondary outcome
* Evaluate the efficacy of UTTR1147A compared with placebo and compared with
vedolizumab
* Evaluate the safety of UTTR1147A compared with placebo and compared with
vedolizumab
* Characterization of the pharmacokinetics of UTTR1147A in patients with CU
* Evaluate the potential relationships between exposure to the medicine and the
efficacy and safety of the research tool
* Evaluate the potential relationships between selected covariates and exposure
to UTTR1147A
* Evaluate the immune response to UTTR1147A
* Evaluate the potential effects of ADAs
* Identify biomarkers that are predictive of the response to UTTR1147A (ie
predictive biomarkers), related to progression to a more severe state of the
disease (ie prognostic biomarkers), related to susceptibility to the
development of adverse events (ie safety biomarkers), that can provide evidence
for UTTR1147A activity (ie pharmacodynamic biomarkers) or increase knowledge
and understanding of the biology of the disease
Background summary
Currently there is no available therapy which achieves sustained remission in
more than 10%-30% of patients with chronic IBD.
UTTR1147A, an IL-22 fusion protein, is a novel therapeutic agent being
developed to promote mucosal healing and achieve sustained clinical
remission while potentially allowing reduction or elimination of the
immunosuppression associated with current therapies for UC.
The safety profile of UTTR1147A, as demonstrated in the Phase I studies,
supports further investigation to compare UTTR1147A with placebo and with
vedolizumab in the induction and maintenance of clinical remission for patients
who have failed conventional therapy.
Study objective
This study will evaluate the safety, efficacy, and pharmacokinetics of
UTTR1147A compared with placebo and compared with vedolizumab in patients with
moderate to severe ulcerative colitis (UC).
Study design
This is a Phase II, randomized, parallel-group, double-blind, double-dummy,
placebo-controlled, multicenter study to evaluate the efficacy, safety, and
pharmacokinetics of UTTR1147A compared with placebo and compared with
vedolizumab in the treatment of moderate to severe
UC.
Intervention
Part A
During Part A, patients will receive IV infusions of UTTR1147A, UTTR1147A
placebo,
vedolizumab, or vedolizumab placebo. At Week 0 only, two IV infusions will be
administered.
At Weeks 2, 4, 6, and 8, patients will receive one IV infusion (see treatment
regimens outlined
above).
Part B
During Part B, patients will receive IV infusions of UTTR1147A and vedolizumab
placebo
(Arms 1A, 2A, and 3A), UTTR1147A placebo and vedolizumab placebo (Arms 1B, 2B,
3B, and
5), or vedolizumab and UTTR1147A placebo (Arm 4) at Weeks 14 and 22.
Study burden and risks
You may get side effects from the medicines or procedures used in this study.
Side effects may vary from mild to very severe and may vary from person to
person. Everyone who participates in the study is closely monitored for any
side effects. Genentech, the research doctor and other doctors do not know all
the side effects that can occur. Your research physician can give you
medication to help reduce these side effects and you may need to temporarily or
permanently stop using UTTR1147A or vedolizumab. Many side effects disappear
quickly after you stop what causes them. In some cases, side effects can be
serious, persist for a long time or never disappear. In rare cases there is
also a risk of death. You should immediately talk with your research physician
about any side effects you get while you are taking part in the study. You
should also tell your research physician if you have started new medication,
including medication that is available free of prescription and alternative
medicines.
Grenzacherstrasse 124
Basel 4070
CH
Grenzacherstrasse 124
Basel 4070
CH
Listed location countries
Age
Inclusion criteria
- Age 18-80 years
- Diagnosis of Ulcerative Colitis (UC)
- Moderate to severely active UC, defined by the Mayo Clinic Score
- Inadequate response, loss of response, or intolerance to prior
immunosuppressant treatment and and/or corticosteroid treatment
- Use of highly effective contraception as defined by the protocol
Exclusion criteria
- History of psoriasis or psoriatic arthritis; any other inflammatory skin
disorders requiring oral corticosteroids, immunosuppressants, or
biological therapy within the previous year and primary sclerosing
cholangitis
- History of cancer as defined by the protocol
- Significant uncontrolled comorbidity, such as cardiac, pulmonary, renal,
hepatic, endocrine, or GI disorders (excluding UC)
- Prior extensive colonic resection, subtotal or total colectomy, or
proctocolectomy, or planned surgery for UC
- Diagnosis of indeterminate colitis or granulomatous (Crohn's) colitis
and toxic megacolon within 12 months prior to screening
- Suspicion of ischemic colitis, radiation colitis, or microscopic colitis
- Current fistula or history of fistula, current pericolonic abscess and
Stricture (stenosis) of the colon
- History or current evidence of unresectable colonic mucosal dysplasia
and high-grade colonic mucosal dysplasia
- Prior treatment with vedolizumab, etrolizumab, natalizumab,
efalizumab, or any other anti-integrin agents and rituximab
- Use of prohibited therapies as defined by the protocol prior to
randomization
- Evidence or treatment of infections or history of infections as defined
by the protocol
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2017-002350-36-NL |
| CCMO | NL64245.028.18 |